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Dental

12,644 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
MULTIPIEZO PRO, MULTIPIEZO (K140965)Mectron S.P.A.2014-08-20
ANKYLOS C/X IMPLANT SYSTEM (K140347)Dentsply Intl., Inc.2014-08-20
STRAUMANN BONE LEVEL TAPERED IMPLANT (K140878)Straumann USA, LLC2014-08-20
HIOSSEN PROSTHETIC SYSTEM (K140507)Osstem Implant Co., Ltd.2014-08-20
MASTERSURG / EXPERTSURG (K140308)Kaltenbach & Voigt GmbH2014-08-15
VONFLEX S BITE (K140966)Vericom Co., Ltd.2014-08-15
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE (K140737)Straumann USA, LLC2014-08-14
ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS (K133255)Dentalpoint AG2014-08-12
Straumann Bone Level NC Angled Screw Retained Abutments (K141871)Straumann USA, LLC2014-08-07
ISY (K133991)Altatec GmbH2014-08-06
FUTURABOND M+ (K141610)Voco GmbH2014-08-01
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM (K133461)Stryker2014-08-01
SILVER DENTAL ARREST (K102973)Cooley Consulting, Inc.2014-07-31
ARGEN PMMA (K140894)The Argen Corporation2014-07-31
ENCOMPASS (K141130)Panoramic Corp.2014-07-30
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM (K141120)Zimmer Dental, Inc.2014-07-29
ZQUIET-SA (K140777)Sleeping Well, LLC2014-07-25
MICR02 OSA DEVICE (K133683)Microdental, Inc.2014-07-24
NOBELPROCERA OVERDENTURE BAR (K132749)Nobel Biocare USA, LLC2014-07-24
FLEXI-LUME LED SYSTEM (K140281)Epic Medical Concepts & Innovations2014-07-24
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER (K140518)Geistlich Pharma AG2014-07-18
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM (K133551)Zimmer Dental, Inc.2014-07-18
PORCINE ANORGANIC BONE MINERAL (K140714)Collagen Matrix, Inc.2014-07-16
ENADEN FLOW (K140976)Km Corporation2014-07-10
BENDA WEDGE (K140144)Centrix, Inc.2014-07-08
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE (K132214)Hager& Meisinger GmbH2014-07-07
Z5C (K132881)Z-Systems AG2014-07-03
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE (K140512)Juno Dentistry LP2014-07-02
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM (K140685)Sybron Endo2014-07-02
BIODENTINE (K140132)Septodont2014-06-27
MEDLEY GOLD (K140435)American Dental Sleep Medicine, Ip, LLC2014-06-26
TRUKLEAR BRACKET (K141104)Ajw Technology Consultants, Inc.2014-06-25
ABSOLUTE DENTIN 2 (K132115)Parkell, Inc.2014-06-25
SATURNO(TM) OVERDENTURE IMPLANT SYSTEM (K133327)Zest Anchors, LLC2014-06-25
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX (K140278)Somnomed, Inc.2014-06-20
PROCEM (K140644)Ototronix, LLC2014-06-19
JR IMPLANT SYSTEM (K130694)LK Consulting Group USA, Inc.2014-06-19
SILDENT (K132869)Hrs Co., Ltd.2014-06-19
CHAIRSIDE ATTACHMENT PROCESSING MATERIAL (K140570)Zest Anchors, LLC2014-06-16
DENTAL IMPLANT SYSTEM (K122807)Hager& Meisinger GmbH2014-06-13
WINX SLEEP THERAPY SYSTEM (K132003)Apnicure, Inc.2014-06-13
BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM (K133884)Biodenta Swiss AG2014-06-13
MTA2.1 MATERIAL (K140955)Avalon Biomed, Inc.2014-06-11
BASE IT (K134022)Spident Co., Ltd.2014-06-11
ESTEMP IMPLANT, ESTEMP CLEAR (K134021)Spident Co., Ltd.2014-06-10
MASTERGRAFT PUTTY (K140374)Medtronic Sofamor Danek USA, Inc.2014-06-10
U FIT DENTAL IMPLANT SYSTEM (K132956)T Strong, Inc.2014-06-05
FLASH PENTA MB QUICK, FLASH MB QUICK (K140602)3M Espe AG2014-06-05
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH (K140481)Colgate-Palmolive Company2014-06-05
STARCERAM (K140924)H.C. Starck Ceramics GmbH2014-06-05
ZIBONE CERAMIC DENTAL IMPLANT SYSTEM (K132585)Coho Technology Co., Ltd.2014-06-04
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) (K133850)Prismatik Dentalcraft, Inc.2014-06-04
X-MIND UNITY (K132378)De Gotzen S.R.L.2014-05-30
T1/T2/T3 TURBINE FAMILY (K131319)Sirona Dental Systems GmbH2014-05-30
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY (K132506)Michael D Williams Dds PA2014-05-29
NIGHT SHIFT (K140190)Advanced Brain Monitoring, Inc.2014-05-29
A-DEC/W&H ELECTRIC HANDPIECE MOTOR (K133776)A-Dec, Inc.2014-05-28
ELASTIC IMPRESSION MATERIAL (K133071)Rizhao Huge Dental Industry Co., Ltd.2014-05-28
SYNERGY (K123876)Odontit S.A.2014-05-22
HYGEDENT ALGINATE IMPRESSION MATERIAL (K140074)Hygedent, Inc.2014-05-21
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) (K132937)Harvest Dental Products, LLC2014-05-21
RXG DISTRACTION SYSTEM (K133304)KLS-Martin L.P.2014-05-15
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT (K133752)Sonendo, Inc.2014-05-15
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM (K133206)Zuma Dental, LLC2014-05-13
ENDOSEAL (K133054)Maruchi2014-05-12
ENDOCEM ZR (K133042)Maruchi2014-05-12
RITTER IMPLANT SYSTEM (K131557)Ritter Implants GmbH CO KG2014-05-09
ADX4000W (K134055)Dexcowin Co., Ltd.2014-05-09
MRNA APPLIANCE (K130067)Biomodeling Solutions, Lls2014-05-08
NOBELACTIVE WIDE PLATFORM (WP) (K133731)Nobel Biocare AB2014-05-08
FILTEK BULK FILL POSTERIOR RESTROATIVE (K141081)3M Espe Dental Products2014-05-08
LUXER SHADED ZIRCONIA (K140070)Continental Dental Ceramics, Inc.2014-05-07
DENRACLE DENTAL ABUTMENT (K131468)Green Dentech Co, Ltd.2014-05-06
MOSTDI DENTAL IMPLANT SYSTEM (K132178)Mostdi Innovations Sdn Bhd2014-04-30
NEW STETIC DENTAL AMALGAM ALLOY (K140125)New Stetic2014-04-29
COMFORTSOFT SOFT DENTURE LINER SYSTEM (K140146)Whip Mix Corp.2014-04-29
ELECTRIC HANDPIECE SYSTEM (K132570)Ttbio Corp.2014-04-29
OPTEO, VIDEOGRAPH HD (K133271)Owandy2014-04-28
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM (K134045)Zimmer Dental, Inc.2014-04-25
MTA FILLAPEX (K140247)Angelus Industria DE Productos Odontologicos SA2014-04-25
THE MOSES ELITE APPLIANCE (K132933)Allen J. Moses, Dds, Ltd.2014-04-25
DX3000-L (K133007)Dexcowin Co., Ltd.2014-04-24
ERGONOMIC PRODUCTS WORKSTATION (K132315)Ergonomic Products, Inc.2014-04-18
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW (K133421)Straumann USA, LLC2014-04-17
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] (K133791)Sterngold Dental, LLC2014-04-16
AIR-FLOW HANDY 3.0 (K132478)E.M.S Electro Medical Systems S.A2014-04-11
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE (K131906)Satelec - Acteon Group2014-04-11
ALL-BOND UNIVERSAL SC (NOT FINALIZED) (K131734)Bisco, Inc.2014-04-11
RETROMTA-ORTHOMTA II (K132825)Biomta2014-04-10
TRC-PASTE (K133716)Km Corporation2014-04-09
HTFX-222 (K133182)GC America, Inc.2014-04-09
MEGA ISQ (K132401)Osstell AB2014-04-09
STRYKER TEMPORARY CONDYLAR PROSTHESIS (K133285)Stryker2014-04-09
MD-FLEX HEAVY BODY (K134008)Meta Biomed, Inc.2014-04-09
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE (K133377)Nobel Biocare AB2014-04-04
QUICK JET M (K133170)Micron Corp.2014-03-28
WHIP MIX PREPPIES PLUS (K131760)Whip-Mix Corp.2014-03-26
ENCORE SYSTEM (K133680)Siesta Medical, Inc.2014-03-26
KERATOR (K132144)LK Consulting Group USA, Inc.2014-03-21
ZIRTOUGH (K133211)Kuraray Noritake Dental, Inc.2014-03-20
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